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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(K) Number K041267
Device Name CARDIQ ANALYSIS III
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS
3000 north grandview blvd.
w-400
waukesha,  WI  53188
Contact larry a kroger
Regulation Number892.1750
Classification Product Code
JAK  
Date Received05/12/2004
Decision Date 05/27/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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